Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218710
Company: PHATHOM PHARMACEUTICALS INC
Company: PHATHOM PHARMACEUTICALS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOQUEZNA | VONOPRAZAN FUMARATE | EQ 10MG BASE | TABLET; ORAL | Prescription | None | No | No |
| VOQUEZNA | VONOPRAZAN FUMARATE | EQ 20MG BASE | TABLET; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/17/2024 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218710s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218710Orig1s000,215151Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218710Orig1s000TOC.html |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/17/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218710s000lbl.pdf |